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Clinical trial Recruiting at 5 sites Interventional Ages 18 and up

Comparing radial and femoral access methods for cardiac catheterization

Official title: Radial vs. State-Of-The-Art Femoral Access for Bleeding and Access SIte Complication Reduction in Cardiac Catheterization (REBIRTH)

Run by Minneapolis Heart Institute Foundation · NCT04077762 · Data updated 2026-11-12

This study is testing whether using the wrist or the groin for heart catheterization is better for patients in terms of satisfaction and complications.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment3266 (estimated)
SponsorMinneapolis Heart Institute Foundation
Academic / other
Locations6 sites (San Francisco, California and 5 other locations)
StatusRecruiting
StartedNovember 15, 2019
Main results expectedAugust 19, 2027
Study endsAugust 19, 2028
Registry record updatedAugust 19, 2026
Trial IDNCT04077762 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 and older who are undergoing diagnostic angiography or planned PCI and are eligible for either radial or femoral access.

Probably not a fit

Patients requiring primary PCI for STEMI or those with specific vascular access issues may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study aims to compare the effectiveness of radial access versus state-of-the-art femoral access in patients undergoing cardiac catheterization without ST-segment elevation acute myocardial infarction. Participants will be randomly assigned to one of the two access methods, with a secondary randomization within the femoral group to evaluate the use of different gauge needles. The study will assess patient satisfaction and the incidence of vascular access complications associated with each method.

Why it matters

Potential benefit: If successful, this study could lead to improved patient outcomes and satisfaction by identifying the safer access method for cardiac catheterization.

How similar studies have gone: Previous studies have shown promising results in favor of radial access, suggesting that this approach may reduce complications compared to femoral access.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Age 18 years and older
* Undergoing diagnostic angiography for ischemic symptoms with possible PCI, or undergoing planned urgent or elective PCI
* Has provided informed consent and agrees to participate
* Patients must be equally eligible to undergo cardiac catheterization via radial or femoral access

Exclusion Criteria:

* Primary PCI for STEMI
* Planned right heart catheterization
* Valvular heart disease requiring valve surgery within 30 days after the index procedure
* Hemodialysis access (arteriovenous fistula or graft) in the arm to be used for PCI in case of assignment to radial approach (the opposite arm may be used for radial access if a dialysis graft is present in one)
* Peripheral arterial disease prohibiting vascular access
* Presence of bilateral internal mammary artery coronary bypass grafts
* International normalized ratio ≥1.5 while treated with oral vitamin K antagonists (i.e. warfarin) Receipt of oral factor Xa or IIa inhibitors ≤24 h before procedure
* Planned staged PCI within 30 days after index procedure.
* Any planned surgeries within 30 days after index procedure
* Planned dual arterial access (for example for chronic total occlusion PCI)
* Coexisting conditions that limit life expectancy to less than 30 days
* Positive pregnancy test

Where it's running

  • San Francisco VA Medical Center
    San Francisco, California, United States     Recruiting
  • Mayo Clinic Florida
    Jacksonville, Florida, United States     Recruiting
  • Joseph Maxwell Cleland Atlanta VA Medical Center
    Decatur, Georgia, United States     Recruiting
  • Minneapolis Heart Institute Foundation
    Minneapolis, Minnesota, United States     Recruiting
  • Oklahoma Heart Hospital
    Oklahoma City, Oklahoma, United States     Recruiting
  • Henry Ford Hospital
    Detroit, Michigan, United States     Not yet recruiting

Study contacts

  • Principal investigator: Emmanouil Brilakis, MD, PhD — Minneapolis Heart Institute Foundation
  • Study coordinator: Bavana Rangan, BDS, MPH, CCRP
  • Email: bavana.rangan@allina.com
  • Phone: 612-863-3852

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Patient Satisfaction 28Vascular Access Complication 7Minneapolis Heart Institute Foundation 11
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.